Identity
- Trade Name
- Zn-Ky Decolorizer EUDAMED
- Device Name
- Myco Reagents EUDAMED
- Model / Reference
- RWM0211A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530733 EUDAMED
- Basic UDI-DI
- 803392853MYCOHV EUDAMED
- Direct Marketing DI
- 08033928530733 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Zn-Ky Decolorizer by Delcon Srl — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 803392853MYCOHV | Class A | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED 3225266e-8565-4bcf-85e0-a49333bbd9f9 61 fields · synced Jul 13, 2026